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Job OverviewThe University of Cincinnati, Hoxworth Blood Center is recruiting for a full-time (100 % FTE), Director, Quality Assurance / Regulatory Affairs, to oversee and direct the coordination of quality assurance and regulatory compliance for the Cellular Therapy, Therapeutic Apheresis, and Transplantation Immunology divisions.
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Assist clients with development of QMS and Quality Systems SOPs as needed based on the clinical or commercial phase of the product, example SOPs include: document control, batch record review and release, production oversight, investigations, CAPA, change control, complaints, recall, QMR, QRM, Training, vendor management, etc.
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Support the Quality group's oversight efforts with quality systems such as change control, quality investigations, CAPA identification and resolution, audits, and any other recommendations to compliance issues and/or observations as they arise.
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Proficient in the development and utilization of quality systems (e.g., deviations and investigations, change control, CAPA, training, CTMS, TMF). Establish effective partnerships with cross-functional departments and leaders (e.g., regulatory affairs, CMC, Clinical Operations, and Product Development) to facilitate the identification and resolution of quality matters and other opportunities for quality process improvement.
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GCP, and GLP Quality Systems responsibilities include training, document management (SOPs and other controlled documents), change control, process improvement, and quality Quality systems activities will be coordinated with the Quality Systems group.
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Primary Job Responsibilities: Responsible for all aspects of company Quality Assurance and Regulatory affairs in compliance with local, state, and federal food safety standards at our dietary supplement manufacturing facility.
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2-5 years regulatory experience and/or 2 years relevant industrial experience typically with a quality, product-development/support, or scientific affairs function. Provides consultation/advice to regulatory specialist for change control and product development.
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Quality assurance, Annual product review, label, change control, Gmp, Fda, quality systems management, pharmaceutical, Audit. Quality assurance,Annual product review,label,change control,Gmp.
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Quality Engineer, QMS, MasterControl, FDA, cGMP, regulatory, New Product Development, Design Change, NSPs. Assist Regulatory Affairs and Engineering personnel in new product process design to ensure effective control procedures are established.
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Seeking candidate with experience with international (outside of EU and US) product registrations; experience working with medical device operations on control of product release; experience working with electronic change management/document control systems.
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Working closely with key business partners in Manufacturing, Facilities, Operations, Regulatory Affairs, and Quality Control; this position will focus on the development of systems to assure compliance to cGMP’s meeting FDA and company goals in an efficient manner.
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The position of Regulatory Affairs Specialist II is within our Infectious Disease business unit. Title: Regulatory Affairs Specialist II. Supports manufacturing/operations day to day activities for change control.
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Experience in Quality Assurance, IT, Quality Control, Validation, Production, or Regulatory Affairs. Be a Subject Matter Expert (SME); you will provide quality oversight and approval of change controls, deviations, and investigations, CAPAs, and Periodic Review assessments involving GxP Computerized Systems.
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This position is responsible for all QA activities that directly support execution of the process both within the Process Execution Team (PET) and in assigned areas outside of the PETs. These activities may include, but are not limited to, batch release, change control and documentation, equipment and process validation, deviation investigations, SOPs, supplier management, distribution center management, and regulatory interactions.
$60,000 - $82,500 a yearFull-timeExpandApply NowActive JobUpdated Yesterday - UpvoteDownvoteShare Job
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Perform regulatory assessment on all proposed change control; gather required data as needed to defend a Regulatory filing strategy; coordinate and prepare post-approval supplements if warranted.
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regulatory affairs change control quality jobs
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